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Arcaea
Boston, MA, United States
Arcaea is a biology-first beauty company building a new ingredient toolset for the beauty and personal care industry. We are creating pioneering ingredients, products, and stories accessible uniquely through biology. Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in biotechnology with the aim of
Job Source: ArcaeaCambridge Isotope Laboratories, Inc.
Tewksbury, MA, United States
Cambridge Isotope Laboratories (CIL) has an outstanding opportunity for a Quality Assurance Specialist I to join the team responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components based onsite in our Tewksbury, MA location. CIL is the global leading company in a highly technical,
Job Source: Cambridge Isotope Laboratories, Inc.CATALDO AMBULANCE
Danvers, MA, United States
Job Description Job Description ALS Quality Assurance (QA) Specialist Job Summary Works with each division Clinical Manager as well as the Senior Clinical Director to monitor and maintain clinical standards. Duties and Responsibilities Work collaboratively with the Clinical Director and Mangers to ensure that proper clinical standards are being
Job Source: CATALDO AMBULANCEKatalyst HealthCares and Life Sciences
Boston, MA, United States
Description: seeking a Quality Assurance Sr. Specialist for real time on the floor quality oversight and lot disposition of Small Molecule GMP manufacturing facility at Moderna Inc. This position will be based in our cGMP Small Molecule Manufacturing site in Cambridge, MA. The individual in this role will be part of a cohesive team responsible fo
Job Source: Katalyst HealthCares and Life SciencesPhaidon International
Billerica, MA, United States
EPM are looking for two Quality Assurance Specialists with extensive experience in compliance responsibilities. The specialist in question will be expected to be On-Site 5 days a week, this would be a non-negotiable! The work would involve experience working with systems such as Trackwise, Veeva or QMS. Duties and Responsibilities: Investigates co
Job Source: Phaidon InternationalGardner Resources Consulting
Boston, MA, United States
Our Pharma client, located in Boston, MA, is currently searching for a Senior Quality Assurance Contractor to help maintain quality systems with a focus on GMP Compliance. The Senior QA Contractor will assist with batch record review and will provide a thorough review and analysis of mission critical data focused on QMS trending and reporting and
Job Source: Gardner Resources ConsultingBrigham and Women’s Hospital
Boston, MA, United States
Job Description - CT Quality Assurance Specialist (3291089) CT Quality Assurance Specialist - ( 3291089 ) Reporting to the Assistant Clinical Director (ACD), of CT the Quality Assurance Specialist facilitates the CT Quality Assurance program and provides appropriate education to the staff which includes assessing, planning, implementing, and
Job Source: Brigham and Women’s HospitalBrigham & Women's Hospital(BWH)
Boston, MA, United States
Reporting to the Assistant Clinical Director (ACD), of CT the Quality Assurance Specialist facilitates the CT Quality Assurance program and provides appropriate education to the staff which includes assessing, planning, implementing, and evaluating both orientation and continuing education programs to enhance the quality of patient care services.Th
Job Source: Brigham & Women's Hospital(BWH)Boston, MA, United States
Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in biotechnology with the aim of delivering radical performance and unparalleled sustainability that will also present new opportunities for storytelling.
Arcaea is seeking an experienced Quality Assurance Specialist to join our team and play a critical role in developing our ingredient toolset for the beauty and personal care industry. As a member of the Arcaea team, you will be responsible for leading Arcaea's QA/QC efforts.
No candidate will meet every single desired qualification. If your experience looks a little different from what we’ve identified and you think you can bring value to the role, we’d love to learn more about you!
WHAT YOU WILL DO:
Author, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, QC and supply chain
Develop a Quality program including the implementation of a Quality Management System
Oversee all QA/QC activities at Contract Manufacturing organizations (CMO) and Contract testing laboratories
Batch Record Review: Review and analyze batch records for adherence to Good Manufacturing Practices (GMP) and internal quality standards
Compliance Monitoring: Collaborate with cross-functional teams to monitor compliance with regulatory requirements and company policies
Review and approval of deviations / non-conformances and lead the strategic discussion for out of specification investigations with respect to operations or validation/qualification related matters
Implement audit program and manage audits
Documentation: Maintain accurate and detailed documentation related to quality assurance activities
Create and/or review and enforce Quality Agreements with CMO partners
Develop and manage the QA/QC budgets
Ensure QC work (analytical and non-analytical) meets quality and timing expectations to support operations
Represent the company with government agencies, vendors, and customers
Support regulatory efforts for the company in all product lines
Communicate QA & QC goals and progress with executive management and external partners as needed
Provide strategic input to Product Development, Manufacturing, and Platform Development initiatives to align with quality plans and budgets
Manage 3rd party testing laboratories including sample logistics
WHAT WE SEEK:
BS/ in Biology, Microbiology, Chemistry, or equivalent experience
5+ years of experience in quality assurance
A working knowledge of 21 CFR 710 FDA regulations
Ability to communicate at all levels of the organization and apprise senior management of critical issues
Familiarity with Good Manufacturing Practices (GMP) and their application in the biotech sector
Familiarity with batch records and their significance in maintaining product quality
Attention to Detail: Strong attention to detail and commitment to maintaining high-quality standards
Startup experience preferred
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Email Alert for Quality Assurance Specialist jobs in Boston, MA, United States
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